A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Two-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of CC-92480; the Relative Bioavailability Among Two Formulations of CC 92480; and Food Effect on the Exposures of Two Formulations of CC 92480 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839809
• Other study ID #: CC-92480-CP-003
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2021
• Est. completion date: October 8, 2021

Study information

• Verified date: December 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only.

• Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants.

• Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

1. Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being conducted.

2. Healthy adult female of nonchildbearing potential or male of any race, between 18 to 55 years of age (inclusive) at the time of signing the ICF, and in good health as determined by the screening history and Physical examination (PE).

3. Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.

4. For males:

a. Practice true abstinence (which must be reviewed on a monthly basis, as applicable) or agree to use a barrier contraception not made of natural (animal) membrane (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of childbearing potential (FCBP) while on study medication, and for at 3 months after the last dose of study medication even if he has undergone a successful vasectomy.

5. For females:

Female participants must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening or be postmenopausal (defined as 24 months without menses before screening, with a serum follicle-stimulation hormone (FSH) level of > 40 IU/L at screening.

6. Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.

7. Clinical laboratory test results must be within the respective reference ranges; or if not, the results be clinically insignificant according to the Investigator's medical judgment.

8. Participant must agree and be willing to consume a standard high-fat meal (which may contain gluten), for Part 2 participants only.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

1. Female of childbearing potential, pregnant, or breastfeeding.

2. History of any clinically significant and relevant neurological, gastrointestinal (GI), renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.

3. History of severe (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous) reaction to a drug, or adverse reactions to multiple drugs.

4. Use of any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 28 days of the first dose administration.

5. Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.

6. Donation of blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.

7. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before first dose administration, or positive drug screening test reflecting consumption of illicit drugs.

8. History of alcohol abuse (as defined by the current version of the DSM) within 2 years before first dose administration, or positive alcohol screen.

9. Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a reactive result to the test for human immunodeficiency virus (HIV) antibodies at screening.

10. Use of tobacco- or nicotine-containing products within 3 months prior to Day -1, as assessed by medical history and physical examination, or positive urine cotinine test at screening.

11. Vaccination within 30 days of first dose administration or plans to receive vaccination (live and attenuated) within 30 days after dosing.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CC-92480
Oral

Other:
• Placebo
Oral

Locations

Country	Name	City	State
United States	PPD Phase 1 Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics- Cmax Part 1	Maximum plasma concentration of drug	Up to 96 hours after dosing
Primary	Pharmacokinetics- Tmax Part 1	Time to maximum plasma concentration	Up to 96 hours after dosing
Primary	Pharmacokinetics- AUC0-8Part 1	Area under the plasma concentration-time curve from time zero to infinity	Up to 96 hours after dosing
Primary	Pharmacokinetics- AUC0-t Part1	Area under the plasma concentration-time curve from time zero to the last observable concentration	Up to 96 hours after dosing
Primary	Pharmacokinetics- t½ Part 1	Terminal elimination half-life	Up to 96 hours after dosing
Primary	Pharmacokinetics- CL/F Part 1	Apparent total plasma clearance	Up to 96 hours after dosing
Primary	Pharmacokinetics- Vz/F Part 1	Apparent volume of distribution	Up to 96 hours after dosing
Primary	Pharmacokinetics- tlag Part 1	Lag time between time of administration and start of absorption	Up to 96 hours after dosing
Primary	Pharmacokinetics- Cmax Part 2	Maximum plasma concentration of drug	Up to 96 hours after dosing
Primary	Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2	Ratio of maximum plasma concentration of drug	Up to 96 hours after dosing
Primary	Pharmacokinetics- AUC0-8 Part 2	Area under the plasma concentration-time curve from time zero to infinity	Up to 96 hours after dosing
Primary	Pharmacokinetics- Ratio of AUC0-8 (Formulation A/Formulation B) Part 2	Ratio of area under the plasma concentration-time curve from time zero to infinity	Up to 96 hours after dosing
Primary	Pharmacokinetics- AUC0-t Part 2	Area under the plasma concentration-time curve from time zero to the last observable concentration	Up to 96 hours after dosing
Primary	Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2	Area under the plasma concentration-time curve from time zero to the last observable concentration	Up to 96 hours after dosing
Primary	Pharmacokinetics- Tmax Part 2	Time to maximum plasma concentration	Up to 96 hours after dosing
Primary	Pharmacokinetics- t½ Part 2	Terminal elimination half-life	Up to 96 hours after dosing
Primary	Pharmacokinetics- CL/F Part 2	Apparent total plasma clearance	Up to 96 hours after dosing
Primary	Pharmacokinetics- Vz/F Part 2	Apparent volume of distribution	Up to 96 hours after dosing
Primary	Pharmacokinetics- tlag Part 2	Lag time between time of administration and start of absorption	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Cmax (high-fat meal)	Maximum plasma concentration of drug	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal)	Ratio of maximum plasma concentration of drug	Up to 96 hours after dosing
Secondary	Pharmacokinetics- AUC0-8(high-fat meal)	Area under the plasma concentration-time curve from time zero to infinity	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-8 (high-fat meal)	Ratio of area under the plasma concentration-time curve from time zero to infinity	Up to 96 hours after dosing
Secondary	Pharmacokinetics- AUC0-t (high-fat meal)	Area under the plasma concentration-time curve from time zero to the last observable concentration	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (high-fat meal)	Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Tmax (high-fat meal)	Time to maximum plasma concentration	Up to 96 hours after dosing
Secondary	Pharmacokinetics- AUC0-24 (high-fat meal)	Area under the plasma concentration-time curve from time zero to 24 hours post dose	Up to 96 hours after dosing
Secondary	Pharmacokinetics- t½ (high-fat meal)	Terminal elimination half-life	Up to 96 hours after dosing
Secondary	Pharmacokinetics- CL/F (high-fat meal)	Apparent total plasma clearance	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Vz/F (high-fat meal)	Apparent volume of distribution	Up to 96 hours after dosing
Secondary	Pharmacokinetics- tlag (high-fat meal)	Lag time between time of administration and start of absorption	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Cmax (low-fat meal)	Maximum plasma concentration of drug	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (low-fat meal)	Ratio of maximum plasma concentration of drug	Up to 96 hours after dosing
Secondary	Pharmacokinetics- AUC0-8(low-fat meal)	Area under the plasma concentration-time curve from time zero to infinity	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-8(low-fat meal)	Ratio of area under the plasma concentration-time curve from time zero to infinity	Up to 96 hours after dosing
Secondary	Pharmacokinetics- AUC0-t (low-fat meal)	Area under the plasma concentration-time curve from time zero to the last observable concentration	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (low-fat meal)	Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Tmax (low-fat meal)	Time to maximum plasma concentration	Up to 96 hours after dosing
Secondary	Pharmacokinetics- t½ (low-fat meal)	Terminal elimination half-life	Up to 96 hours after dosing
Secondary	Pharmacokinetics- CL/F (low-fat meal)	Apparent total plasma clearance	Up to 96 hours after dosing
Secondary	Pharmacokinetics- Vz/F (low-fat meal)	Apparent volume of distribution	Up to 96 hours after dosing
Secondary	Pharmacokinetics- tlag (low-fat meal)	Lag time between time of administration and start of absorption	Up to 96 hours after dosing
Secondary	Incidence of Adverse Events (AEs)	An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.	From enrollment until at least 28 days after completion of study treatment